title: Effect of treatment interruption and intensification of antiretroviral therapy on health-related quality of life in patients with advanced HIV: a randomized, controlled trial.
abstract: The effect of antiretroviral therapy (ART) interruption or intensification on health-related quality of life (HRQoL) in advanced HIV patients is unknown.
  
  
  
  To assess the impact of temporary treatment interruption and intensification of ART on HRQoL.
  
  
  
  A 2 x 2 factorial open label randomized controlled trial.
  
  
  
  Hospitals in the United States, Canada, and the United Kingdom.
  
  
  
  Multidrug resistant (MDR) HIV patients.
  
  
  
  Patients were randomized to receive a 12-wk interruption or not, and ART intensification or standard ART.
  
  
  
  The Health Utilities Index (HUI3), EQ-5D, standard gamble (SG), time tradeoff (TTO), visual analog scale (VAS), and the Medical Outcomes Study HIV Health Survey (MOS-HIV).
  
  
  
  There were no significant differences in HRQoL among the four groups during follow-up; however, there was a temporary significant decline in HRQoL on some measures within the interruption group during interruption (HUI3 -0.05, P = 0.03; VAS -5.9, P = 0.002; physical health summary -2.9, P = 0.001; mental health summary -1.9, P = 0.02). Scores declined slightly overall during follow-up. Multivariate analysis showed significantly lower HRQoL associated with some clinical events. Limitations. The results may not apply to HIV patients who have not experienced multiple treatment failures or who have not developed MDR HIV.
  
  
  
  Temporary ART interruption and ART intensification provided neither superior nor inferior HRQoL compared with no interruption and standard ART. Among surviving patients, HRQoL scores declined only slightly over years of follow-up in this advanced HIV cohort; however, approximately one-third of patients died during the trial follow up. Lower HRQoL was associated with adverse clinical events.
authors.affiliation: VA Palo Alto Health Care System, VACooperative Studies Program Coordinating Center, VA HSR&D Health Economics Resource Center, Menlo Park, California (VRJ, PGB, AC)
authors.forename: Vilija R
authors.initials: VR
authors.lastname: Joyce
authors.affiliation: VA Palo Alto Health Care System, VACooperative Studies Program Coordinating Center, VA HSR&D Health Economics Resource Center, Menlo Park, California (VRJ, PGB, AC)
authors.forename: Paul G
authors.initials: PG
authors.lastname: Barnett
authors.affiliation: VA Palo Alto Health Care System, VACooperative Studies Program Coordinating Center, VA HSR&D Health Economics Resource Center, Menlo Park, California (VRJ, PGB, AC)
authors.forename: Adam
authors.initials: A
authors.lastname: Chow
authors.affiliation: Centre for Research on Inner City Health, The Keenan Research Centre in the Li Ka Shing Knowledge Institute and Division of General Internal Medicine, St. Michael’s Hospital, Toronto, Ontario, Canada and Departments of Medicine and Health Policy, Management and Evaluation, University of Toronto, Ontario, Canada (AMB)
authors.forename: Ahmed M
authors.initials: AM
authors.lastname: Bayoumi
authors.affiliation: Centre for Health Economics, University of York, York, United Kingdom (SCG, MS)
authors.forename: Susan C
authors.initials: SC
authors.lastname: Griffin
authors.affiliation: Centre for Health Evaluation and Outcome Sciences, St. Paul’s Hospital, Vancouver, British Columbia, Canada (HS)|Canadian HIV Trials Network, Vancouver, British Columbia, Canada (HS, AHA)
authors.forename: Huiying
authors.initials: H
authors.lastname: Sun
authors.affiliation: VA Palo Alto Health Care System, Palo Alto, California (MH, DKO)
authors.forename: Mark
authors.initials: M
authors.lastname: Holodniy
authors.affiliation: James J. Peters VA Medical Center, Bronx, New York (STB)
authors.forename: Sheldon T
authors.initials: ST
authors.lastname: Brown
authors.affiliation: VA Cooperative Studies Program Coordinating Center, West Haven, Connecticut (TCK)
authors.forename: Tassos C
authors.initials: TC
authors.lastname: Kyriakides
authors.affiliation: Division of Infectious Diseases, University of Ottawa at the Ottawa Hospital Research Institute, Ottawa, Ontario, Canada (DWC)
authors.forename: D William
authors.initials: DW
authors.lastname: Cameron
authors.affiliation: Royal Free Hospital, London, United Kingdom (MY)
authors.forename: Mike
authors.initials: M
authors.lastname: Youle
authors.affiliation: Centre for Health Economics, University of York, York, United Kingdom (SCG, MS)
authors.forename: Mark
authors.initials: M
authors.lastname: Sculpher
authors.affiliation: Department of Health Care and Epidemiology, University of British Columbia, Vancouver, British Columbia, Canada (AHA)
authors.forename: Aslam H
authors.initials: AH
authors.lastname: Anis
authors.affiliation: VA Palo Alto Health Care System, Palo Alto, California (MH, DKO)|Center for Primary Care and Outcomes Research, Stanford University, Stanford, California (DKO)
authors.forename: Douglas K
authors.initials: DK
authors.lastname: Owens
mesh_terms: D000328:Adult; D044966:Anti-Retroviral Agents / Q000008:administration & dosage*; D002170:Canada; D003266:Continuity of Patient Care; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D005260:Female; D015658:HIV Infections / Q000188:drug therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D011788:Quality of Life / Q000523:psychology*; D012720:Severity of Illness Index; D006113:United Kingdom; D014481:United States
chemical_list: D044966:Anti-Retroviral Agents